跳至主要内容
临床试验/NCT06930339
NCT06930339进行中(未招募)不适用

Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis

Helius Medical Inc1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150
试验地点
1
主要终点
Effectiveness of PoNS Therapy as measured by self-reported change in symptomatology

研究概览

简要总结

The Registry will be designed to gather information over 3 years. This important health economic information will help to establish the value of the PoNS Device on key therapeutic outcomes. These outcomes will include:

disease-associated injury risks (i.e., falls), onset of new comorbidities and/or worsening/improvement of existing medical condition(s) (other than gait deficit/impairment), need for new pharmacological/non-pharmacological intervention or increase/decrease of ongoing pharmacotherapy or other non-pharmacological intervention, increase/decrease of in patient/outpatient hospital and/or office visits or stays, side effects.

By participation in the Registry, patients and physicians will be providing Helius with access to information about medical history, medical diagnoses, clinical symptom presentations, vocational information, medications, pharmacologic and non-pharmacologic prescriptions, hospitalization and healthcare visits, and any reported therapy's adverse events.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
22 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of gait deficit due to MS

排除标准

  • unable to ambulate with or without an assisting device

结局指标

主要结局

Effectiveness of PoNS Therapy as measured by self-reported change in symptomatology

时间窗: 3 years

Balance and Gait deficit improvement after physical therapy rehabilitation with PoNS device over one or more courses of 14-week therapy

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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